Clinical trial
The Median Effective Dose of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room: An Up-and-Down Sequential Allocation Trial
Name
2023ZSLYEC-402
Description
Due to sleep deficiency, patients with insomnia syndrome or sub-clinical insomnia syndrome often undergo severe stress while waiting for surgery. Studies have reported that preoperative hypnosis could reduce stress and promote recovery. Midazolam has been recommended to patients who under severe stress for preoperative sedation and anti-anxiety. However, midazolam for preoperative hypnosis monitored with polysomnography (PSG) has not been studied. In this exploratory study, the median effective dose (ED50) and ED95 of Midazolam Oral Solution for preoperative hypnosis in non-elderly adults using the gold standard tool of PSG, will be explored by up-and-down sequential allocation and probit method.
Trial arms
Trial start
2023-08-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Not yet recruiting
Treatment
Midazolam oral solution
The ED50 dose of midazolam oral solution for hypnosis is studied using an up-and-down sequential allocation while waiting for surgery and general anesthesia in preoperative room.
The starting dose is 6 mg and the step size is 1 mg. The interval sequential dose is varied by 1 mg based on the hypnosis response of the previous patient after one hour.
Definition of successful hypnosis by taking midazolam oral solution:
The polysomnograph (PSG) not only shows stage N2 within 30 minutes, but also shows stage N3 within an hour; or else, definition of unsuccessful hypnosis.
The procedure is as follows: (1) The first subject is given 6mg of midazolam oral solution; (2) If succeed, the second subject takes 4mg; (3) If not succeed, the second subject takes 8mg; (4) Until seven sequence reversal inflection points.
Arms:
An Up-and-Down Sequential Allocation
Size
40
Primary endpoint
The Median Effective Dose (ED50) of Midazolam Oral Solution
Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Eligibility criteria
Inclusion Criteria:
1. Signed of informed consent voluntarily;
2. Native Chinese speaker;
3. Age 18-60 years old, male or female;
4. BMI 18-30 kg/m2;
5. American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠorⅡ;
6. Non-emergency cancer resection surgery is planned in the next day;
7. Insomnia syndrome or sub-clinical insomnia syndrome in the past 1 month.
Exclusion Criteria:
1. Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution);
2. High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points);
3. Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1\~6 years≤22 points; above of 6 years≤26 points);
4. Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15);
5. History of Neurological and Psychiatric diseases (According to the electronic medical record system);
6. History of Chronic Obstructive Pulmonary Disease (According to the electronic medical record system);
7. History of Heart Failure (According to the electronic medical record system);
8. Intestinal obstruction(The electronic medical record system records those who currently have any type of intestinal obstruction);
9. Liver and renal insufficiency;
10. Have taken opioids or drugs that act on the central nervous system within one week;
11. Take CYP3A4 isoenzyme inhibitors or inducers within one week (According to the Instruction for Midazolam Oral Solution);
12. Consume any alcoholic beverage within 24 hours;
13. Substance abusers (including alcohol, drugs or addictive substances);
14. Pregnant or lactating women;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-08-30
1 organization
1 product
3 indications
Product
MidazolamIndication
doseIndication
MidazolamIndication
Preoperative